title: A randomized, double-blind, placebo-controlled study to test the efficacy of topical 2-hydroxypropyl-Beta-cyclodextrin in the prophylaxis of recurrent herpes labialis.
abstract: Herpes labialis affects one third of the population. We evaluated the topical application of an antiviral compound, hydroxypropyl-β-cyclodextrin (2-HPβCD), in reducing herpes labialis relapses. In this double-blind, randomized, placebo-controlled trial, 40 patients were randomized to a polyethylene glycol (PEG) formulation containing 20% 2-HPβCD or to a vehicle control arm. The gel was applied to the lips twice daily for 6 months. The primary objective was reducing herpes relapses. Surprisingly, the drug group had significantly more relapses than the vehicle group (p = 0.003). While the median numbers of relapses in the preceding year were 12 in the vehicle group and 10 in the drug group, both groups experienced very few relapses during the 6-month treatment period, with a median of 0 in the vehicle group and a median of 2 in the drug group. The impressive reduction of relapses in both groups may be due to a placebo effect or due to the topical treatment with PEG.
authors.affiliation: Clinical Trials Center, University Hospital Zurich, Zurich, Switzerland. gabriela.senti@usz.ch
authors.forename: Gabriela
authors.initials: G
authors.lastname: Senti
authors.forename: Reto
authors.initials: R
authors.lastname: Iannaccone
authors.forename: Nicole
authors.initials: N
authors.lastname: Graf
authors.forename: Manuela
authors.initials: M
authors.lastname: Felder
authors.forename: Fabian
authors.initials: F
authors.lastname: Tay
authors.forename: Thomas
authors.initials: T
authors.lastname: Kündig
mesh_terms: D000073738:2-Hydroxypropyl-beta-cyclodextrin; D000212:Acyclovir / Q000627:therapeutic use; D000287:Administration, Topical; D000328:Adult; D000998:Antiviral Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D005782:Gels / Q000627:therapeutic use; D006560:Herpes Labialis / Q000517:prevention & control*; D006801:Humans; D008875:Middle Aged; D014677:Pharmaceutical Vehicles / Q000627:therapeutic use; D011092:Polyethylene Glycols / Q000627:therapeutic use; D055502:Secondary Prevention; D055815:Young Adult; D047392:beta-Cyclodextrins / Q000008:administration & dosage / Q000627:therapeutic use*
chemical_list: D000998:Antiviral Agents; D005782:Gels; D014677:Pharmaceutical Vehicles; D047392:beta-Cyclodextrins; D000073738:2-Hydroxypropyl-beta-cyclodextrin; D011092:Polyethylene Glycols; D000212:Acyclovir